Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery
8 août 2026 mis à jour par: Dong-Xin Wang, Peking University First Hospital
Fascia Iliaca Block Using Liposomal Bupivacaine for Analgesia After Hip Surgery: a Randomized Trial
Patients after hip surgery often suffer from severe pain.
Inadequate analgesia increases the risk of postoperative delirium, myocardial injury, and other complications.
Peripheral nerve block is an important component of multimodal analgesia, but conventional local anesthetics (such as plain bupivacaine) provide only approximately 12 hours of analgesic duration, which is far from covering the most painful 72 hours after surgery.
Liposomal bupivacaine has a slow-release property, prolonging the analgesic duration up to 72 hours after a single injection.
However, its clinical advantages in hip fracture surgery remain controversial.
The investigators suppose that, compared with plain bupivacaine alone, preoperative supra-inguinal fascia iliaca block using liposomal bupivacaine combined with plain bupivacaine can further improve analgesia, decrease opioid consumption, and improve postoperative recovery quality within 72 hours in older patients after hip fracture surgery.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
Hip joint diseases are among the major disorders that impair patients' motor function and quality of life. With the acceleration of population aging and the advancement of hip reconstruction techniques, the number of patients undergoing hip arthroplasty has continued to increase. Hip arthroplasty primarily includes hemiarthroplasty and total hip arthroplasty (THA), with indications covering a variety of diseases and injuries, including osteonecrosis of the femoral head, hip osteoarthritis, ankylosing spondylitis, developmental dysplasia of the hip, and other conditions that lead to structural destruction and functional impairment of the hip joint. Hip arthroplasty can effectively relieve pain, improve joint function, and enhance patients' quality of life, and has become an important treatment modality for end-stage hip joint diseases.
Optimizing analgesia through multimodal strategies can enhance postoperative recovery and shorten hospital stays. Peripheral nerve blocks (PNB), particularly ultrasound-guided femoral nerve block or supra-inguinal fascia iliaca compartment block (FICB), have been shown to reduce pain and opioid consumption after hip surgery. A recent prospective cohort study indicated that better perioperative pain control with PNB is associated with lower opioid needs and shorter hospitalization.
Conventional local anesthetics like ropivacaine or bupivacaine provide analgesia for about 12 hours, which is insufficient for the entire perioperative period. Liposomal bupivacaine, an extended-release formulation, can provide analgesia for up to 72 hours. Some studies have demonstrated benefits of liposomal bupivacaine for nerve blocks in thoracic and hip surgeries, including improved recovery quality, reduced opioid use, and lower pain scores at 24-72 hours. However, evidence remains controversial; several meta-analyses suggest that while statistical differences exist, clinical relevance may be limited.
Inadequate pain control negatively affects postoperative outcomes and is associated with delirium, myocardial injury, and pulmonary complications-especially in vulnerable older patients with reduced physiological reserve and multiple comorbidities. Therefore, this randomized controlled trial aims to investigate whether preoperative FICB using liposomal bupivacaine combined with plain bupivacaine can provide superior perioperative analgesia compared with plain bupivacaine alone in older (≥55 years) patients undergoing hip fracture surgery.
Type d'étude
Interventionnel
Inscription (Estimé)
148
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Dong-Xin Wang, MD, PhD
- Numéro de téléphone: 010-83572784
- E-mail: wangdongxin@hotmail.com
Sauvegarde des contacts de l'étude
- Nom: Zhen Zhang, MD
- Numéro de téléphone: +86 13681035526
- E-mail: zhangzhen1st@163.com
Lieux d'étude
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100034
- Peking University First Hospital
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Contact:
- Dong-Xin Wang, MD, PhD
- Numéro de téléphone: 010-83572784
- E-mail: wangdongxin@hotmail.com
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Aged ≥ 18 years.
- Scheduled to undergo hip replacement surgery.
- Agree to receive regional nerve block and postoperative patient-controlled intravenous analgesia (PCIA).
Exclusion Criteria:
- Inability to communicate due to visual, auditory, language, or other reasons before surgery.
- Chronic opioid dependence and long-term use of various types of analgesics (for more than 3 months).
- Severe coagulation abnormalities (International Normalized Ratio > 1.7, activated partial thromboplastin time exceeding the normal value by more than 4 seconds, platelet count < 80 × 10⁹/L), trauma or infection at the intended puncture site, or severe low back pain.
- Preoperative severe renal insufficiency (serum creatinine > 442 μmol/L or requiring renal replacement therapy), hepatic insufficiency (Child-Pugh class C), or ASA physical status > IV.
- Known allergy to local anesthetics.
- Any other condition that the investigator or attending physician deems unsuitable for participation in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Liposomal bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block.
The mixture used for nerve block will consist of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), for a total volume of 30 mL.
The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle.
The block will be performed in the preoperative holding area.
|
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be perfomed using a mixture of 10 mL of 0.5% plain bupivacaine plus 20 mL of liposomal bupivacaine (266 mg), total volume 30 mL.
The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle.
The block will be performed in the preoperative holding area.
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Comparateur actif: Plain bupivacaine group
Participants in this arm will receive a single preoperative ultrasound-guided supra-inguinal fascia iliaca block.
The mixture used for nerve block will consist of 30 mL of 0.5% plain bupivacaine (total 150 mg).
The mixture will be injected after negative aspiration and under real-time ultrasound visualization to confirm correct needle tip position between the fascia iliaca and the iliacus muscle.
The block will be performed in the preoperative holding area.
|
A single preoperative ultrasound-guided supra-inguinal fascia iliaca block will be performed using 30 mL of 0.5% plain bupivacaine (150 mg).
The injection will be performed after negative aspiration and under real-time ultrasound visualization to ensure proper spread between the fascia iliaca and the iliacus muscle.
The block will be performed in the preoperative holding area.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The area under curve of pain intensity within 72 hours after surgery
Délai: Up to 72 hours after the surgery
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Pain intentsity will be assessed with the numeric rating scale (NRS; an 11-point where 0=no pain and 10=the worst pain) at 2, 6, 12 hours and then very 12 hours, until 72 hours after surgey.
The area under curve of pain intensity will be calculated using the trapezoidal rule.
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Up to 72 hours after the surgery
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cumulative opioid consumption within 72 hours after surgery
Délai: Up to 72 hours after the surgery
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Cumulative opioid consumption will be calculated as intravenous morphine equivalent dosage.
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Up to 72 hours after the surgery
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Incidence of cardiovascular events within 7 days after surgery
Délai: Up to 7 days after surgery
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Cardiovascular events includes myocardial injury, non-fatal cardiac arrest, and all-cause death.
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Up to 7 days after surgery
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Durée du séjour à l'hôpital après la chirurgie
Délai: Jusqu'à 30 jours après la chirurgie
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Durée du séjour à l'hôpital après la chirurgie
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Jusqu'à 30 jours après la chirurgie
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Incidence of moderate-to-severe pain within 72 hours after surgery
Délai: Up to 72 hours after surgery
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Moderate-to-severe pain is defined as a NRS pain score of 4 or higher at any timpoint.
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Up to 72 hours after surgery
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Quality of recovery at 24 hours after surgery
Délai: At 24 hours after surgery
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Quality of recovery will be assessed with the quality of recovery-15 (QoR-15; a 15-item questionnaire that evaluat the quality of early postoperative recovery after surgery and anesthesia.
Scores range from 0 to 150, with higher scores indicating better quality of recovery).
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At 24 hours after surgery
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Incidence of complications within 30 days after surgery
Délai: Up to 30 days after surgery
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Postoperative complications are generally defined as new-onset conditions that are deemed harmful and required therapeutic intervention, i.e., grade 2 or higher on the Clavien-Dindo classification.
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Up to 30 days after surgery
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The proportion of patients receiving rescue analgesics within 72 hours after surgery.
Délai: Up to 72 hours after surgery
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Rescue analgesics are defined as any analgesic drugs other than PCIA, including opioids, acetaminophen, non-steroid anti-inflammatory drugs, and other analgesics.
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Up to 72 hours after surgery
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Cumulative score of subjective sleep quality during the first three nights after surgery
Délai: Up to three nights after surgery
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Subjective sleep quality will be assessed with the numeric rating scale (NRS; an 11-point where 0=the best sleep and 10=the worst sleep).
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Up to three nights after surgery
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Incidence of acute kidney injuy within 7 days after surgery
Délai: Up to 7 days after surgery
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Acute kidney injury (AKI) will be diagnosed according to the 2012 KDIGO (Kidney Disease: Improving Global Outcomes) creatinine criteria.
AKI is diagnosed if any one of the following criteria is met: (1) An increase in serum creatinine (SCr) by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours; (2) An increase in serum creatinine to ≥ 1.5 times the baseline value, which is confirmed or presumed to have occurred within the past 7 days.
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Up to 7 days after surgery
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Dong-Xin Wang, MD, PhD, Peking University First Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Chahar P, Cummings KC 3rd. Liposomal bupivacaine: a review of a new bupivacaine formulation. J Pain Res. 2012;5:257-64. doi: 10.2147/JPR.S27894. Epub 2012 Aug 14.
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- Desmet M, Vermeylen K, Van Herreweghe I, Carlier L, Soetens F, Lambrecht S, Croes K, Pottel H, Van de Velde M. A Longitudinal Supra-Inguinal Fascia Iliaca Compartment Block Reduces Morphine Consumption After Total Hip Arthroplasty. Reg Anesth Pain Med. 2017 May/Jun;42(3):327-333. doi: 10.1097/AAP.0000000000000543.
- Beaudoin FL, Haran JP, Liebmann O. A comparison of ultrasound-guided three-in-one femoral nerve block versus parenteral opioids alone for analgesia in emergency department patients with hip fractures: a randomized controlled trial. Acad Emerg Med. 2013 Jun;20(6):584-91. doi: 10.1111/acem.12154.
- Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.
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- Ilfeld BM, Eisenach JC, Gabriel RA. Clinical Effectiveness of Liposomal Bupivacaine Administered by Infiltration or Peripheral Nerve Block to Treat Postoperative Pain. Anesthesiology. 2021 Feb 1;134(2):283-344. doi: 10.1097/ALN.0000000000003630.
- Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23.
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Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 août 2028
Dates d'inscription aux études
Première soumission
7 juin 2026
Première soumission répondant aux critères de contrôle qualité
7 juin 2026
Première publication (Réel)
12 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
8 août 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026R0311
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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